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Exam Code: GP-Doctor Practice exam 2022 by Killexams.com team
General Practitioner (GP) Doctor
Medical Practitioner basics
Killexams : Medical Practitioner basics - BingNews https://killexams.com/pass4sure/exam-detail/GP-Doctor Search results Killexams : Medical Practitioner basics - BingNews https://killexams.com/pass4sure/exam-detail/GP-Doctor https://killexams.com/exam_list/Medical Killexams : Upscaling Health Practitioners Skill in Basic, Advanced Life Support

Sunday Ehigiator reports that to upscale the basic and advanced life support skills, Smile Train, world largest cleft charity organisation, recently partnered the Federal Ministry of Health by sponsoring the National Surgical, Obstetrics, Anaesthesia and Nursing Plan to train health practitioners

Recently, there was a trending video shared across various social media platforms of a man who appeared to have suffered a cardiac arrest while dancing at an occasion.

While the man fell to the ground, and appeared to be choking and gasping for air, other attendees at the party watched on the premise that he was still performing l.

Eventually, they realised it was beyond a dance routine and immediately rushed out to help. However, the video clearly showed that none of them understood what he was going through, hence didn’t know how to help, and unfortunately, the report was that the man died.

Such is the case of cardiac arrest. It is sudden, unplanned and can happen to anybody at anywhere or at any time. Hence, everyone alive is vulnerable to suffering a cardiac arrest, and having a basic knowledge of how to perform a basic Cardiopulmonary Resuscitation (CPR) is a good way to go.

This was why Smile Train found it necessary to champion the cause, by training healthcare workers with prerequisite first-aid techniques needed to resuscitate anyone who suffers a cardiac arrest.

In her opening remarks, Smile Train Program Director for West and Central Africa, Mrs. Nkeiruka Obi, explained that the National Surgical, Obstetrics, Anaesthesia & Nursing Plan (NSOANP) programme “agrees with Smile Train’s mission of empowering health practitioners to boost health coverage”.

Mrs. Obi, who was ably represented by Smile Train’s Program Manager for West Africa, Victoria Awazie, added that the organisation’s intervention was also to ensure that the NSOANP programme is actualised.

“Smile Train has given life to the NSOANP Nigeria project. We have signed a MoU with the Federal Ministry of Health for implementation of the NSOANP. We also have a partnership on a cleft e-registry platform aimed at mapping out patients with clefts to enable them to have access to free and quality care.

“There is a need for us to equip our healthcare professionals with basic life-saving skills that meet the needs of under-served communities”, she stressed.

Also speaking with THISDAY, Pediatric Surgeon, and Research Assistant at NSOANP, Dr. Justina Olajide added that part of the goals of the National Surgical Plans for Nigeria was to train people to be proficient in delivering Basic Life Support (BLS) and Advanced Life Support (ALS).

“BLS is not just for healthcare providers but also for the populace as well, so that anyone who develops a condition that needs the intervention will get it, whether in the hospital, church or home, or community. And we believe that this is going to lead to a lot of improved health matrix for the country, and that was what led to this training.

“To implement this, we needed sponsorship, and so we had to rely on development partners. Smile Train rose up as a development partner to help with the implementation of the surgical plan. And one of the entry points Smile Train is using is training people to deliver basic life support to the population in the country, and that is why this program is holding.”

On the two days training, Mrs. Olajide described the feedback as fantastic. “Everybody learnt so much, acquired new skills, and we’re encouraged to go back to their centres, encourage directors in their hospitals to set up similar training, using them as trainers. So we expect a step down of what they have learnt to be passed on to others”.

One of the trainers, also an Anesthesiologist from Ghana, Anastasia Ohene, while speaking with THISDAY said the essence of the training was to empower as many healthcare workers to be able to provide first aid or BLS and ALS.

According to her, “you never know when someone can collapse or have a cardiac arrest, and we want as many healthcare workers as possible to be ready to provide the necessary help needed by such a patient.

“We know that the more people train in BLS, the more confident they are to give the support. Sometimes, when cardiac arrest happens, there are people who are trained, but because they are not confident, or sure, they are reluctant to act. But the more they are trained, the more confident they become, and likely to always help when the need arises.

“The healthcare workers are also part of the general population. They can go further to teach more people on these skills, whether in schools, banks, market places etc. So that many Nigerians are skilled up in BLS and are confident to help whenever the need arises.”

Speaking about her experience after the training, a Pediatrician, from the Federal Medical Centre, Abeokuta, Dr. Dedeke Olabisi showered praises on the organisers who afforded her an opportunity to have a formal training in BLS for the first time in her career.

“It’s very important for us to have training and retraining. We know that people have cardiac arrest almost every few seconds.

So it’s very important for me as a trainer myself, and also a trainee, so that I can up my skills in resuscitation and ensure that if anybody around me has cardiac arrest, the person survives it.

“So, for me, it’s highly impactful training. The people seated here are from different hospitals, it’s expected that upon leaving this place, plans would be made in their various hospitals on how they can further train other staff of the hospital just as they have been trained.”

Speaking on some causes of cardiac arrest, she said “there are so many reasons why people would have cardiac arrest. They may have infection, or may have been in shock, or react to things or choke as they are eating etc. As simple as throwing groundnuts into the mouth can make anybody choke, just like talking while eating, we just need to be careful.

“People even choke on their saliva and are gone. Little things such as talking while eating or chewing gum, can just cause cardiac arrest, we just need to be very careful, live a healthy lifestyle, and preach preventive measures in our home,” she noted.

Also speaking with THISDAY, Consultant Anesthetist, at the Federal Medical Center, Owo, Dr. Akinwonmi Olugbenga described the training as awesome.

“I have learnt quite a lot, in terms of the new equipment and changes in the CPR, basic life support, and even the practical session. The training has provided us with an opportunity to perfect our skills and also opportunities to be corrected in a few places we had lapses.

“And this would translate to gains when we get back to our field at our various workplaces, and we will give back to our patients and train more people on these new techniques.

“I really want to thank Smile Train and NSOANP for making it possible for us to have this kind of program. It is a well thought program that is going to have a positive impact on the larger population of Nigeria,” she added.

Thu, 06 Oct 2022 12:00:00 -0500 en-US text/html https://www.thisdaylive.com/index.php/2021/06/10/upscaling-health-practitioners-skill-in-basic-advanced-life-support/
Killexams : Elevating the Health of Girls, Worldwide

Violence against women and girls starts early: Based on a accurate large-scale review of violence against women prevalence studies across the globe, WHO found that nearly 1 in 4 adolescent girls who have had an intimate relationship have been subjected to physical and/or sexual violence by an intimate partner at least once in their lifetime.

Violence against children and youth, particularly sexual violence against girls, is a global human rights and public health crisis. Experiencing violence in childhood and adolescence can profoundly impact emotional and physical health and social development.

Girls are at higher risk for experiencing gender-based violence (GBV) – including sexual violence and physical violence – than boys. GBV is any form of violence against an individual based on biological sex, gender identity, or expression, or being perceived to be a man, woman, boy, or girl based on socially defined expectations. GBV can include physical, sexual, and psychological abuse; threats; coercion; and freedom, including financial, taken away to make decisions about one’s own life. GBV is also rooted in gender-related power differences that are complex and operate at an individual, relational, and societal level.

close up of young girl

Teen girl in India looks contemplative.

GBV is also linked to economic insecurity. Those who live in chronic poverty may find themselves more likely to experience situations in which they must risk violence to access fundamental resources. For example, an adolescent girl may be forced to exchange sex for material resources to meet her basic needs. In addition, those who are financially insecure may be more likely to live in locations that are prone to conflict, have fewer support services, and offer weaker legal protections. The COVID-19 pandemic has led to increases in levels of violence occurring in the home, including violence against children, and intimate partner violence. This has created challenges in maintaining support and care for those most in need.

Efforts to understand how often violence happens, where it occurs, and its impacts on the health and well-being of children and youth are a first step in preventing violence globally. High-quality, timely data delivers critical information to develop prevention strategies that help policymakers and practitioners make decisions as they select, adapt, and implement activities to prevent and respond to violence against children.

CDC and Together for Girls is a broad partnership between national governments, United Nations (UN) entities, and private sector organizations, that work at the intersection of violence against children and women to encourage prioritization, prevention, and response, with special attention to sexual violence against girls. Learn more about this network of partnerships and their work: Linking Violence Against Children and Youth Surveys to Coordinated and Effective Action: CDC and the Together for Girls Partnership.

Thu, 06 Oct 2022 12:00:00 -0500 en-us text/html https://www.cdc.gov/healthequity/features/girls/index.html
Killexams : Affordable Health Care Is Possible Overseas

One of the biggest benefits of retiring overseas can be finding affordable health care and dramatically reduced health insurance. Here in Panama, for example, our English-speaking doctor charges US$35 for a visit. And if your problem isn’t cured after the first visit and you need to see him again… the follow-up is free. If you become a resident of Portugal, health care can be free. You get the idea. In conclusion, affordable or free health care isn’t necessarily the point, is it? More important is the quality of the care.

Here, again, I have good news. Health care overseas, as assessed by the World Health Organization (WHO), can be superior to care available in the United States. Indeed, in the WHO’s annual survey of health care across the globe, the United States ranks 37th. Here are six top retirement destinations where the health care is affordable and better than in the States.

1. France

A bird in a park with green grass with the Eiffel Tower in the background in Paris, France
Adobe Stock/Givaga

France’s health care system, made up of a network of public and private hospitals, doctors, and other services providers, is ranked the best in the world by the WHO.

France offers universal health care financed by Sécurité Sociale, its national insurance system. Citizens and residents of France can choose their general practitioner from a network of 94,000—one of the highest number of GPs in the European Union.

You can access France’s health care system by paying social security contributions, which means most of the cost the extraordinary medical care is covered. Even paying out of pocket, though, the care is affordable. A basic consultation with a GP costs about 25 euros.

For access to English-speaking doctors, resources like Doctolib.fr are available, which lets you filter medical professionals by their backgrounds. If you’re adamant about seeing American doctors, the American Hospital in Paris, as well as Franco-Britannique, which is staffed by British doctors.

2. Italy

Medieval houses and La Rocca Hill, Cefalu, Sicily, Italy.
Alamy/Jan Wlodarczyk

Coming in second place in the WHO’s rankings of global health care systems is Italy. Its national health service is called the Servizio Sanitario Nazionale (SSN), and it provides care at public hospitals, access to GPs and certain specialists, subsidized medicines, and more at little to no cost.

Public health care is managed by Italy’s regional governments, and there are discrepancies in the standards of care available across the country. The best health care in the country is found in the northern and central regions of Italy.

As a resident of Italy, you can access public health care by registering with the SSN and paying an annual fee. You will need to have an Italian identity card to be able to apply for an Italian health insurance card, which allows you to register with a local hospital.

Some expats opt to pay for insurance to gain access to Italy’s private hospitals, which are more like five-star hotels than hospitals. This allows for more freedom of choice of doctors and facilities, shorter wait times, and more comforts, although it comes at a cost.

3. Malta

Marsaxlokk bay harbour of Malta, with beautiful architecture and boats at dusk
Adobe Stock/cristianbalate

Malta has a long tradition of providing excellent health care. It opened its first hospital in 1372. The Knights Hospitaller, a Catholic military order that provided humanitarian and medical support, was headquartered in Malta from 1530 to 1798.

During World War I, the country became known as the Nurse of the Mediterranean because so many wounded soldiers were sent there to recover.

Today, the WHO ranks Malta’s health care system fifth best in the world, and with a number of state-of-the-art public and private facilities staffed by highly trained staff who are fluent in English, it has a burgeoning reputation as a medical tourism destination.

Public health care is mostly free at the point of delivery, as well as prescribed medicine if you’re a hospital inpatient (and for three days after being discharged). Primary care is delivered by Malta’s 415 general practitioners while secondary and tertiary care is delivered at public hospitals.

Malta also has an excellent private health care system, and as a foreign resident, you’re required to have private insurance. Premiums are considerably lower than they are in the United States.

4. Portugal

Porto, Portugal
Adobe Stock/neirfy

Portugal’s health care system is ranked 12th best in the world by the WHO. It boasts a modern, well-equipped hospital network where about 90% of medical staff is English-speaking. Portugal has one of the highest number of GPs per 100,000 inhabitants in the EU at 292.3.

Three systems provide health care in Portugal: The Serviço Nacional de Saúde (SNS, or the National Health Service), voluntary private health insurance, and health insurance schemes for specific professions.

As a resident of Portugal, you can access the SNS, which covers all basic health, by registering with your local health center. While not completely free, SSN user fees are low, for instance, GP appointments cost 5 euros, while emergency care costs 15 euros.

Public health care in Portugal is hampered by long wait times to receive care. It’s common for expats to supplement public care with insurance that allows them to access private facilities.

5. Colombia

Night View of Cartagena de Indias, Colombia
Adobe Stock/sunsinger

Colombia has the best health care in Latin America, offering highly skilled doctors, well-equipped hospitals, and excellent care at affordable prices. It’s long been known as a destination for cosmetic surgery and other advanced procedures.

Colombia’s health care system is ranked #22 by the WHO. The basic public health insurance plan is called Entidades Promotoras de Salud (EPS), and it’s inexpensive and easy to acquire. It’s similar to a preferred provider organization in that you must seek care within a preferred network of providers.

Some expats opt to pay for additional care or pay out of pocket to receive care faster, as it takes time to navigate the EPS system. Moreover, many doctors are English-speaking because they trained in the United States or Europe, although the level spoken among other medical staff is lower.

Medical procedures can cost one-third to one-tenth the cost of comparable care in the United States, most importantly, this includes nursing homes, where costs are far lower than they are in the States, and the quality of care is the same if not better.

6. Cyprus

Lala Mustafa Pasha Mosque and Famagusta town. Famagusta, Cyprus
Adobe Stock/ kirill_makarov

Cyprus is another burgeoning medical tourism destination, particularly for IVF treatments, complex investigations, and dental care. Costs are low enough that many pay out of pocket. The average price to see a specialist medical practitioner with a same-day appointment is about 45 euros.

The WHO ranks Cyprus 24th in the world for overall health system performance. It operates a multi-payer system consisting of a public and private sector. The General Healthcare System (GESY) is the state-run system, which you can gain access to as a resident of Cyprus.

Across Cyprus, you’ll find private and state-run clinics and hospitals as well as surgeries, emergency medical facilities, dentists, opticians, and even alternative health care options. As a result, pharmacies are abundant as well, and staff can recommend treatments for minor ailments.

A range of medications are available, and prices can be as low as one-third the cost of equivalent care in the States.

If you are looking for detailed information, here is a Complete Guide To Health Care And Health Insurance Options Overseas.

Sincerely,
Kathleen Peddicord signature


Kathleen Peddicord
Founding Publisher, Overseas Opportunity Letter
Fri, 14 Oct 2022 09:39:00 -0500 en-US text/html https://www.liveandinvestoverseas.com/affordable-health-care-overseas/
Killexams : Privacy Basics: A Quick HIPAA Check for Medical Device Companies

Regulatory Outlook

HIPAA

HIPAA, which was enacted in 1996, had many different goals, including making insurance transferable upon leaving employment, enabling electronic billing for medical costs, and, the most famous result, the authorization of federal privacy rules for health information. The Department of Health and Human Services (HHS) then made two regulations: the HIPAA privacy rule, which regulates private health information, and the HIPAA security rule, which regulates the manner in which healthcare providers control and protect health information.

Covered Entities

The organizations controlled by the HIPAA privacy regulation are called covered entities. A covered entity is any healthcare provider that electronically bills for its services. This covers almost all healthcare professionals. It also means that most medical device companies are not covered entities. However, some medical device firms that sell to patients and bill Medicare may qualify as covered entities and be bound by HIPAA. For example, a company that sells insulin pumps to patients and bills Medicare would be a covered entity. Some companies may have a subsidiary that is a covered entity while the rest of the company is not covered; such companies are called hybrids. The company can wall off the subsidiary, which is a covered entity, so that only that part of the company is bound by HIPAA.

Covered Information

HIPAA defines the covered information as PHI, which is any health-related information that may identify a patient. HIPAA takes an expansive view of what may identify a person. There is a list of 18 identifiers. Besides the traditional identifiers such as name, address, phone number, social security number, etc., there are some device-related identifiers, such as serial number or date of service when the device was used, that have proven quite to difficult to deidentify.

Almost any information from a patient file has to be carefully scrutinized to be sure it is not PHI. The definition is wider in the United States than it is in the European Union (EU), where more-traditional identifiers are used. Member nations of the EU are governed by the EU Directive on Data Privacy.

Disclosure of PHI

Authorization is the term used for a patient to allow some disclosure or use of PHI. HIPAA determines authorized uses of PHI by covered entities and what disclosures of PHI may be made. The HIPAA privacy regulation outlines when a covered entity must obtain authorization from the patient or approval from an institutional review board (IRB) or privacy board.

Note that the EU uses the term consent for this document while HIPAA uses authorization. For device companies, there may be an informed consent document created to comply with FDA clinical rules or the HHS Common Rule. This consent document may have a HIPAA authorization built into it, but the HIPAA authorization is not called a consent.

With several exceptions, a covered entity may use PHI within its organization without restriction by HIPAA. However, when it discloses information outside its boundaries, the covered entity must comply with the HIPAA privacy regulation's limitations and authorization requirements. The covered entity may disclose to third parties without authorization for three HIPAA-specified activities: treatment, payment, or healthcare operations (TPO).

Treatment. Treatment refers to communication of PHI needed to treat the patient, such as information flow between the covered entity and another healthcare provider, e.g., another doctor who is treating the patient. A general practitioner and a specialist may discuss their joint patient for the purpose of treatment without activating any authorization requirements under HIPAA. This treatment exception could involve a medical device company. For example, if a technical representative from a medical device company takes part in a surgery to help use or train surgeons on the company's equipment, that participation is part of treatment and does not require an authorization. Although it is wise to notify the patient before exposing his or her data or personal information to a company representative, there is no specific HIPAA requirement to do so under these circumstances.

Payment. Payment refers to the process of obtaining payment from payers such as insurance carriers. Although covered entities routinely ask for consent to disclose information to payers, and there may be consent requirements at the state level, there is no need for a HIPAA authorization for billing.

Healthcare Operations. The term healthcare operations refers to the internal mechanics of running the covered entity. PHI may be transmitted as part of normal business operations. For example, the covered entity may use PHI for internal quality assurance improvement practice.

Business Associates

Sometimes a covered entity receives assistance in performing activities that involve the use or disclosure of PHI under HIPAA. The person or entity providing the help is called a business associate. A covered entity may enter a business associate agreement (BAA) with another person or company that is providing services to the covered entity with regard to TPO. For example, the covered entity might outsource its billing department to a third party. In such a case, the covered entity would engage that biller with a BAA.

It is very unusual for a medical device company to need a BAA with any covered entity. In the early days of HIPAA, covered entities were wholesale shipping BAAs to everyone they purchased from. Since then, HHS has made it clear that the normal relationship between a medical device provider and a covered entity does not require a BAA.

It is only when a medical device company is acting on behalf of a covered entity that it needs a BAA. One narrow example is when a covered entity is prescreening patient records in preparation for research. It can do that without an authorization. However, if the covered entity allows a third party, such as a device company, onto its property to do such preliminary searching on the covered entity's behalf, it may then need a BAA to protect the PHI that the device company will access.

Access to PHI

There are a number of access points to PHI for a device company. Some information is necessary for the device company to have and some is thrust upon it. Common ways to be exposed to PHI include the following.

Treatment. As a device company, you have a role in treatment. For example, as previously discussed, a device company representative may attend the real use of a device. Or, a doctor may call the OEM's technical services staff with questions about how a particular patient's anatomy or medical symptoms could affect the use of the company's device. Even though no name is given, the medical data may include HIPAA identifiers. Such treatment interactions between the medical device company and the covered entity are part of the treatment exception to HIPAA and therefore require no special authorization.

Accidental Exposure. A device company field representative may accidentally be exposed to PHI while at the site of a covered entity. For example, the representative might inadvertently see a patient chart while in a doctor's office. HIPAA calls this incidental disclosure. HIPAA allows such action without any repercussions under the regulation. Remember that PHI is still private and the company representative should not disclose what is accidentally seen to anyone else.

Clinical Trial or Other Research Information. There are three main routes for obtaining PHI from a covered entity for research: authorization, partial waiver from an IRB, or deidentification.

The most common way to obtain research data is through patient authorization. An authorization is built into the informed consent document in most medical device clinical trials. Once a company is in the process of having a patient sign a consent form, it is not much extra work to include the additional elements required for a HIPAA-compliant authorization. This method makes it possible to obtain wider access to use of the data. Most device companies want to harness the data to Improve future generations of devices and not just the immediate use. Such usage can be accounted for in a signed authorization.

A partial waiver means asking an IRB to allow PHI of a limited nature to be disclosed without a patient's authorization. For example, the site could strip out all directly identifiable information such as names, addresses, etc. The remaining identifiers might technically identify the patient, but the IRB may determine that the risk is low and allow disclosure without patient authorization. However, this process has proven difficult in practice simply due to the bureaucracy that has to be managed; companies have found the IRB interface to be too slow and laborious to use often.

Deidentification requires removing all 18 identifiers from the PHI, which can be difficult for device research. For example, because device serial numbers are often needed to correlate to other records, they are a hard identifier to do without. Similarly, dates of visits are often needed to correlate to device performance over time. However, deidentification is still a viable option for some research.

Compliance with FDA Regulations. A specific section of the HIPAA privacy regulation allows a covered entity to disclose information to a device manufacturer in order for the manufacturer to report to a public health agency, such as FDA. This exception is crucial because it allows a covered entity to communicate with a manufacturer to follow up on a complaint, provide data for a medical device report, track devices, or use information needed for quality system regulation compliance.

PHI after Disclosure

Once outside a covered entity, HIPAA rules no longer apply to this information. In fact, this must be stated in every HIPAA authorization. However, there are myriad state laws that control PHI in different forms, and if the PHI is obtained under a BAA, there are contractual obligations as well. Therefore, a device company should only take PHI when needed and must safeguard it, i.e., only those who truly need access to PHI should be allowed to see it. Device companies must also establish procedures to prevent accidental disclosure.

Conclusion

HIPAA has definitely made research more difficult for device companies. Each time that a company considers accessing PHI, it needs a thorough HIPAA analysis. Initially, device companies feared that the public health exemption was not broad enough and that covered entities would resist releasing the necessary PHI. However, over time, covered entities have cooperated and have generally allowed access to PHI that device companies need for compliance with FDA regulations. Therefore, life is more difficult with HIPAA, but certainly not impossible.

Copyright ©2009 Medical Device & Diagnostic Industry

Tue, 11 Oct 2022 12:00:00 -0500 en text/html https://www.mddionline.com/news/privacy-basics-quick-hipaa-check-medical-device-companies
Killexams : Medical Imaging: The Basics of FDA Regulation

IMAGING

Image courtesy of SIEMENS (Malvern, PA)

Medical imaging is playing a large and increasing role in modern healthcare delivery. Physicians and other healthcare professionals routinely rely on the diagnostic information provided by advanced imaging techniques such as ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI) in their clinical practices. Surgeons, interventional cardiologists, and interventional radiologists employ a variety of state-of-the-art techniques to guide percutaneous treatments and interventions. Understanding FDA's regulatory construct that governs medical imaging is crucial to manufacturers operating in this exciting and challenging environment.

Regulation of Existing Imaging Technologies

Devices used in medical imaging are considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Medical Device Amendments of 1976 and subsequent related amendments.1,2 Most existing medical imaging technologies are considered non-510(k)-exempt Class I and Class II medical devices by FDA, making them eligible for clearance under the 510(k) pathway.

Under this pathway, new medical devices that are substantially equivalent to existing, legally marketed Class I and Class II devices in terms of intended use, indications for use, and technological characteristics may be cleared for the U.S. market. The legally marketed devices with which comparison is made are referred to as predicate devices.

Under the 510(k) pathway, a next-generation imaging technology may be found substantially equivalent. However, the intended use and indications for use of the device must remain essentially unaltered. Intended use generally refers to the overall purpose of a device. The indications for use define the particular conditions or locations to which the device is to be applied. Also, any technological differences in comparison to the predicate device must not raise new questions of safety or effectiveness. However, if a new intended use or indication for use is sought, or if the technology employed raises new questions of safety or effectiveness when compared with the predicate, the new device is designated as Class III and requires a premarket approval (PMA) application. The PMA process requires a demonstration of safety and effectiveness prior to the granting of marketing approval.

Advanced imaging techniques, such as those used in the Gemini GXL from Philips (Andover, MA), are changing healthcare delivery.

Existing imaging devices use a variety of technologies to obtain diagnostic information or guide therapeutic procedures. These devices may be broken down into modalities that use and those that do not use ionizing radiation to form medical images.

Imaging Devices Using Ionizing Radiation. X-rays are the oldest form of medical imaging. They generate images, known as radiographs, by using ionizing radiation. The majority of the equipment used to produce, control, and process x-rays to generate radiographs is Class I or Class II. real classification (depending on the type of device) ranges from Class I 510(k)-exempt products such as diagnostic x-ray tube housings, which produce the x-ray beam, to Class II non-510(k)-exempt solid-state x-ray imagers or digital flat panels.

X-ray devices are representative of the product evolution that is possible in the 510(k) pathway. Such devices have become progressively more sophisticated, moving from purely analog imaging methods (i.e., the x-rays pass through the body part being imaged and directly onto a film, which is then processed for interpretation) to modern digital methods (i.e., the x-ray strikes a detector system, which then converts the received x-rays into an image). This evolutionary change was made possible by successive technological improvements in predicate devices over time, all generally cleared via the 510(k) pathway.

A notable exception is digital mammography, for which FDA has required PMA approval. The original designation of digital mammography as Class III is attributed to both its indications for use (detection of breast cancer) and the application of new technology to that indication. Currently, there is serious consideration being given to downclassifying it to Class II.

Fluoroscopy, which is closely related to x-ray imaging, allows both static and dynamic x-ray imaging. Like x-ray, fluoroscopy is a long-established imaging process that has undergone considerable technological advances since 1976, all essentially within the 510(k) pathway. Modern digital fluoroscopic equipment, which allows for image processing and manipulation, would have been technically impossible in 1976. Yet it is now considered Class II and subject to a variety of special controls.

CT scanners existed prior to 1976 and were placed into Class II by the original medical device classification panels. As for x-ray and fluoroscopic technology, the 510(k) path allowed CT technology to progress from fairly simple single x-ray source-and-detector configurations to the sophisticated spiral and multidetector technologies available today. FDA regulations describing what constitutes a CT scanner for regulatory purposes are fairly typical of the general nature of such regulations in medical imaging. A CT scanner is defined as

[A] diagnostic x-ray system intended to produce cross-sectional imaging of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis component parts and accessories.3

The FD&C Act is not the only FDA regulation applicable to x-ray, fluoroscopy, CT scanners, and other medical imaging devices that emit ionizing radiation and certain other types of energy. The Radiation Control for Health and Safety Act of 1968 (subsequently incorporated into the FD&C Act at Sections 531–542) addresses such devices. It authorizes FDA to promulgate performance standards for these radiation- and energy-emitting products to minimize unnecessary emission and exposure.4 This legislation applies to any ionizing or nonionizing electromagnetic or particulate radiation; or sonic, infrasonic, or ultrasonic waves emitted from an electronic product as a result of an electronic circuit. Accordingly, any imaging device that emits ionizing radiation marketed in the United States must meet FDA performance standards as well as gain 510(k) clearance.5 The content of the often-complex reports required to satisfy these requirements may be found in various sections of 21 CFR Parts 1000–1050.

Imaging Devices Not Employing Ionizing Radiation. A growing number of medical imaging products do not rely on ionizing radiation to produce images. Diagnostic ultrasound technologies also existed before 1976. Regulated as a Class II device, diagnostic ultrasound has incorporated a number of substantial technological advances since 1976. The result is a variety of features (i.e., color Doppler vascular imaging and 3-D imaging) that vastly Improve its diagnostic capabilities. Like advances in x-ray, fluoroscopy, and CT scanning, diagnostic ultrasound's considerable evolutionary progress has been possible within the 510(k) process. Notably, its Class II designation includes a variety of imaging transducers for both external and internal use, including intravascular ultrasound catheters used for imaging coronary arteries. In addition to the FD&C Act requirements, ultrasound equipment is also subject to FDA performance standards developed under the Radiation Control for Health and Safety Act, given the emission of ultrasonic waves from these devices.

MRI uses powerful magnetic fields in conjunction with radio-frequency pulses and sophisticated computer algorithms to produce detailed anatomic and functional images. Unlike the previous modalities, clinically usable MRI technology was not developed until the early 1980s and consequently had no predicate device when first brought to market. Because the risk to patients undergoing the then-new procedure was not well characterized, MRI was initially regulated as a Class III device and entered the market through the PMA process. Following the widespread clinical introduction of MRI, considerable clinical data were collected demonstrating the relative safety of the technique. Based on this well-defined risk profile, FDA reclassified MRI, MR spectroscopy, and related coils as Class II devices effective July 28, 1988, allowing them to gain marketing approval via the 510(k) pathway.

Related Imaging Management Equipment. In modern clinical practice, medical imaging devices are only part of the medical imaging enterprise. Images obtained by these devices must be captured, stored, and distributed for both primary interpretation and clinical review. This typically requires a picture archiving and communications system (PACS) together with a variety of related components.

PACS devices and their related components depend on computer workstation technology that was not available in 1976. There also was confusion among manufacturers as to whether these products were medical devices, and if so, how they were to be regulated. Culminating in a final rule issued on April 29, 1998, FDA clarified its treatment of PACS and related devices.6 Under these regulations, medical image storage devices and medical image communications devices are Class I exempt if they do not use irreversible compression. PACS devices, along with medical image digitizers (e.g., film scanners) and medical image hard-copy devices (e.g., film printers), are considered Class II and subject to 510(k) premarket notification. Accordingly, PACS devices, medical image digitizers, and medical imaging hard-copy devices require FDA clearance before they may be legally marketed.

Bringing a New Medical Imaging Device to Market

X-rays are the oldest form of internal medical images.

Given that the majority of medical imaging technology is subject to the 510(k) pathway or is even 510(k) exempt, it might appear that bringing new imaging devices to market is a relatively straightforward process. However, this may not be the case if a new product differs from its potential predicate devices in intended use or indications for use, or if it uses modified or new technology. Even if a new device is considered to present a low risk of patient injury, such changes can have a substantial effect on the product's path to market.

Alterations to an Intended Use or Indications for Use. A new imaging device's intended use is key to determining whether that new product is substantially equivalent to a claimed predicate device.7 If a new device's intended use is determined to be not substantially equivalent (NSE) to a predicate device, the new product is subject to an automatic Class III designation. In practice, the broad intended uses of medical imaging devices generally afford sponsors considerable latitude in identifying an intended use that is reasonably applicable to a new imaging product.

The 510(k) pathway allows sponsors some flexibility with a new device's indications for use. Generally, differences in a new device's indications for use as compared with its predicates' does not preclude a substantially equivalent determination. Of course, those differences must not alter the product's intended diagnostic or therapeutic effect. When examining whether such alterations exist, FDA looks to whether the change affects the device's safety and effectiveness compared with that of its predicates.

In practice, minor alterations in the indications for use for an existing imaging technology are often not viewed by FDA as altering a product's diagnostic or therapeutic effect. An example is limiting the application of a cleared imaging technology to a specific area of the body.

More-pronounced changes to a device's indications for use, such as incorporating disease-specific claims (i.e., cancer detection) where the predicate products made only general imaging claims, may cause difficulties in establishing substantial equivalence. In such instances, FDA could easily see the modified indication as affecting the device's diagnostic effect. A relevant example is FDA's treatment of digital mammography. The addition of a breast cancer–screening claim to a breast-specific refinement of digital imaging technology was a major factor in FDA's classification decision. In that case, FDA did require a PMA, even though similar, existing digital imaging systems without a specific cancer-screening indication had been subject to 510(k) clearance. The decision to require a PMA for digital mammography was difficult for many in the imaging community to accept. Nonmammography digital imaging systems with broad indications for use were routinely used in the diagnosis and management of cancer, despite the lack of an explicit cancer-related indication for use. Simply put, even the most established imaging technology may be subject to the PMA pathway if a new indication significantly alters that technology's established diagnostic effects.

Alterations to Device Technology. Assuming that the intended use of a new device is unchanged from its predicates and the indications for use do not alter its diagnostic or therapeutic effect, the substantial equivalence analysis shifts to the technology used to create the images. Should that technology be substantially similar to that of the new product's predicate devices, substantial equivalence is established.

However, if a new product's technology differs from that of the predicate devices, the question becomes whether the change could significantly affect safety or effectiveness. If the answer is no, as might be the case with a minor alteration to image manipulation capabilities or the algorithm by which those images were generated, the product is considered substantially equivalent. However, if the change in technology might significantly affect safety or effectiveness, the analysis moves to whether that change does in fact raise new questions of safety or effectiveness.

The analysis of whether new technological characteristics raise new concerns of safety or effectiveness is often the key question with innovative imaging products. Such products often use completely new methods to obtain diagnostic information. Even if such technology is unquestionably safe, the novel nature of a new device's technology may raise questions of effectiveness. For example, if the imaging technology does not impart energy of any kind into the patient or uses a type of energy whose risks are well characterized, FDA may question the technology's effectiveness. Whenever a new device's technological characteristics do raise new questions, the agency's substantial equivalence analysis ends with an NSE determination.

Consider instances where FDA accepts that no new questions of safety and effectiveness have been raised by a new imaging device's technology. A sponsor must still demonstrate that accepted scientific methods exist for assessing the new technological characteristics and present performance data obtained using those methods to prove substantial equivalence. In practice, clinical data are frequently necessary to establish that the technology has safety and efficacy comparable to its predicates. Designing and conducting clinical studies to demonstrate comparable safety and effectiveness may be difficult. Typically, it requires demonstration of the new product's clinical utility. This, in turn, generally requires the use of the new device to evaluate a specific clinical condition whose existence can be confirmed with a reasonable degree of confidence. This confirmation allows the sensitivity and specificity of the new imaging product to be compared with its predicate devices in a clinical setting in which the new device is to be used.

Approaches to a Not Substantially Equivalent Determination. Should FDA determine that the intended use of a new imaging device differs from that of its predicates, that its indications for use change its effect, or that it raises new questions of safety or effectiveness, agency policy requires that the new device be found NSE.

There are certain indications from FDA that an NSE determination is likely. These include a letter requesting additional information and containing questions that the sponsor cannot address with data that are either on hand or reasonably available.

There are several strategies for dealing with an NSE decision, depending on the underlying basis for the determination.

One potential reason for an NSE decision could be that the intended use has gone beyond the predicate device's intended use. For example, a particular indication for use, such as a claim that an imaging device can either screen for or characterize certain forms of cancer, may require the submission of extensive clinical data or a PMA prior to receiving marketing approval.8 Abandoning or modifying that particular indication, assuming that there were no agency questions with regard to the device's underlying technology, may allow the product to be cleared via the 510(k) pathway.

Similarly, it is not unusual for FDA to object to particular aspects of a new device's technology, such as a specific pulse sequence or imaging algorithm. Removing the portion of the new product's technology that has raised the agency's concern may often allow a substantial equivalence determination to be made on a modified, although less-capable, version of the device.

In instances where a novel new imaging device is low risk but NSE to a predicate device, de novo downclassification under Section 513(f)(2) of the FD&C Act may be an option. Under this pathway, the new device is downclassified into Class I or Class II and subsequently cleared by the agency. FDA will note that a particular device may be eligible for the de novo pathway in the letter notifying the sponsor of the agency's NSE decision. However, if the de novo pathway is being considered, the downclassification should be discussed well before any 510(k) notice is submitted.

To qualify for de novo downclassification, the new imaging device must meet the statutory requirements for inclusion in either Class I or Class II. Administratively, the sponsor must submit a written request for downclassification within 30 days of receiving an NSE letter. The request should include a description of the device, the rationale for the downclassification, and information to support the request. This submission should also discuss proposed general or special controls for the new product that can provide reasonable assurance of its safety and effectiveness.

In practice, clinical data are often necessary, and the downclassification request is typically prenegotiated with FDA. Submission of that request is usually made immediately following the agency's pro forma issuance of an NSE determination. These considerations notwithstanding, FDA has 60 days following the submission of the written request to downclassify the new device. If the agency finds that the product is properly classified in Class I or Class II, the device may be commercially distributed based on the information submitted as part of the de novo downclassification request. However, if FDA finds that the new device is appropriately in Class III, the new device is subject to the PMA process. Although attractive in concept, the de novo process is still used infrequently.

In instances where FDA will not consider either the 510(k) or de novo pathways for a medical imaging device, the PMA pathway is the only option to bring a new imaging device to market. Under the PMA paradigm, clinical trials are necessary to demonstrate that the device is reasonably safe and effective for its intended use and indications for use. As noted earlier, designing clinical studies for imaging products can be challenging, particularly demonstrating a new device's effectiveness and clinical utility. Depending on the particulars of the technology, these studies may have to demonstrate not only that the device can successfully detect a disease or condition with a certain sensitivity and specificity, but also that physicians and other healthcare professionals can use the information provided in a clinically useful manner. Even in instances where the clinical trials for a PMA are comparable in size and complexity with those needed for a 510(k) notice or de novo downclassification, sponsors of a PMA-pathway device are typically subject to substantially higher user fees and a preapproval manufacturing inspection.

Conclusion

FDA regulation of medical imaging devices may appear to some as deceptively simple, because the majority of imaging products are subject to the 510(k) pathway. However, when a sponsor is contemplating new or modified indications for use for an established imaging technology, a variation of established technology, or a totally new technology, the sponsor should fully and realistically explore the potential regulatory consequences.

When developing a substantial equivalence argument for such a product, it is often prudent to consider alternatives to the planned device in terms of intended use and technology, in case FDA initially rejects the claim of substantial equivalence. In considering these options, sponsors should also perform a realistic assessment of the resources available to design and develop clinical trials should clinical data be necessary for 510(k) clearance or should de novo downclassification or a PMA prove necessary.

John J. Smith is counsel at Hogan & Hartson LLP (Washington, DC) where he specializes in regulatory and scientific issues related to FDA marketing approval for medical devices. Smith can be contacted at [email protected].


Reference

1. Federal Food, Drug, and Cosmetic Act, Public Law 75-717, 52 Stat. 1040 (1938), 21 USC Sections 301–394.

2. Medical Device Amendments of 1976, Public Law 94-295, 90 Stat. 539 (1976; codified as amended in scattered sections of 21 USC).

3. Code of Federal Regulations, 21 CFR 892.1750.

4. Radiation Control for Health and Safety Act of 1968, Public Law 90-602, 82 Stat. 1171 (1968).

5. Code of Federal Regulations, 21 CFR 1040.

6. Federal Register, 63 FR:23385, April 29, 1998.

7. “Guidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3),” Blue Book Memorandum (Rockville, MD: FDA, CDRH, 1986).

8. “Guidance for Industry: General/Specific Intended Use” (Rockville, MD: FDA, CDRH, 1998).

Copyright ©2006 Medical Device & Diagnostic Industry

Wed, 12 Oct 2022 12:00:00 -0500 en text/html https://www.mddionline.com/radiological/medical-imaging-basics-fda-regulation
Killexams : Back to basics: Understanding ICD-10-CM coding guidelines and clinical examples

Four organizations, otherwise known as the Cooperating Parties, are responsible for maintaining the ICD-10-CM code set: the American Hospital Association, American Health Information Management Association, CMS, and the National Center for Health Statistics. Coders must understand that conventions, general guidance, and chapter-specific guidelines should also be utilized when coding for outpatient services and office visits.

Thu, 06 Oct 2022 05:58:00 -0500 en text/html https://www.healthleadersmedia.com/revenue-cycle/back-basics-understanding-icd-10-cm-coding-guidelines-and-clinical-examples
Killexams : What to know about a basic metabolic panel (BMP)

A BMP is a group of tests to measure eight different chemicals that occur naturally in the blood. The tests can inform doctors about a person’s organs and overall health.

This article discusses a BMP, its uses, why a person may need it, and what happens during the test. It also considers the risks, results, and how it compares with a comprehensive metabolic test (CMP).

A BMP is a blood test that provides doctors with information about the body’s levels of electrolytes, fluid balance, and kidney function.

Healthcare workers usually perform these tests on the plasma part of the blood.

The test measures eight different chemicals in the blood:

  • Electrolytes: Carbon dioxide, sodium, potassium, and chloride. These electrically charged minerals help control the balance of acids and bases and the level of fluids in the body.
  • Calcium: This is an essential mineral that helps keep the heart, nerves, and muscles functioning properly.
  • Glucose: The body’s main energy source.
  • Blood urea nitrogen (BUN) and creatinine: These are waste products that the kidneys remove from the body.

This test is also known as a chemistry screen, chemistry panel, chem 7, or electrolyte panel.

A doctor can use a BMP to check various body functions. These include:

A doctor may perform a BMP as part of a regular health checkup. A person may also need a BMP if a doctor monitors them for particular chronic conditions, such as kidney disease or high blood pressure, or if doctors treat them in an emergency room.

If a person has abnormal levels of any of the eight substances in a BMP test, they may be at risk of a serious health issue.

A person will experience the following during a BMP blood test:

  1. A healthcare professional, such as a doctor or nurse, will insert a small needle into a vein in a person’s arm.
  2. They will collect a blood demo into a vial or test tube, which typically takes less than 5 minutes and may cause a slight stinging feeling.
  3. The healthcare professional will send the blood demo to a lab for analysis.

What happens after the test?

After the healthcare professional has drawn a blood sample, they will remove the needle and may place a small bandage or piece of cotton wool over the injection site to stop any bleeding.

A person may have slight bruising or tenderness where the needle entered the skin, but symptoms usually resolve quickly.

A laboratory machine will process the test results for the lab technicians and doctors to analyze. If the results of the test show abnormalities, the doctor may order further tests to diagnose the issue.

How can people prepare for the test?

A person may need to stop eating or drinking for 8 hours before the test.

To make it easier to access the injection site, people should wear short-sleeved shirts or T-shirts to their appointment. They should also discuss any medications they are currently taking and any accurate illnesses with the doctor.

Learn more about fasting before blood tests.

Risks for a blood test are minimal. An individual may experience slight bruising or a little pain at the injection site, but these symptoms typically go away quickly. Some people may feel faint for a little while after the test.

BMP results will become available after analysis at a laboratory, which can take a few days.

If a BMP reveals that a person has abnormal levels of any of the chemicals measured, it could indicate various medical conditions. These include:

Following abnormal results, a doctor may order further tests to determine what is affecting the person and how best to treat them.

Learn more about how long it takes to receive blood test results.

Healthy ranges

This chart shows the ranges for the different chemicals tested during a BMP, according to the American Board of Internal Medicine (ABIM).

Abbreviations:

  • mg = milligram
  • mmol = millimole
  • mEq = milliequivalents
  • L = liter
  • dL = deciliter = 0.1 liter

A complete or comprehensive metabolic panel (CMP) is similar to a BMP, except it measures 14 substances instead of eight in the blood.

Alongside the eight chemicals a BMP measures, a CMP also looks at levels of:

A doctor may favor a CMP over a BMP in cases where they believe the person may have a liver or kidney condition, or to monitor the effects of certain medications. A CMP may also be part of a regular checkup.

A person can discuss whether a BMP would be appropriate with a healthcare professional. Otherwise, a doctor may suggest a BMP to help evaluate a person’s health status.

Here are some answers to common questions about BMPs.

Should people fast for a basic metabolic panel test?

Sometimes, a healthcare professional may ask a person to avoid eating or drinking for 8 hours before the test.

A doctor will inform a person if they need to fast.

Is it concerning to have an abnormal BMP test result?

Abnormal results could be due to various reasons, including side effects of medicines. The doctor will discuss the results of each test with the individual and may perform or order further tests to determine what is affecting them.

A basic metabolic panel (BMP) refers to a group of blood tests measuring the levels of eight substances in the blood. The tests can provide doctors with information about the body’s levels of electrolytes, fluid balance, and kidney function.

Abnormal levels of any of these substances could indicate various health issues, such as issues with the kidneys, breathing, or glucose levels.

Individuals can receive a BMP as part of their regular checkup or if a doctor orders the test while diagnosing a health condition. The test is quick and has minimal risk.

If a BMP reveals abnormal results, a doctor may order further tests to help them diagnose and treat an illness.

Tue, 04 Oct 2022 12:00:00 -0500 en text/html https://www.medicalnewstoday.com/articles/bmp
Killexams : Shalom Project hunting for a new home for medical clinic

Jeffrey Foster, the program director at the Shalom Project, greeted the man who’d walked into the nonprofit’s offices Thursday morning like he was a regular customer at the corner store.

The man had popped into the Green Street United Methodist Church — currently a main location for the Shalom Project, a nimble do-everything nonprofit that meets those in need where they live — because he needed a few items. Clothing and toiletries mostly.

Jeffrey Dean Foster, program manager, closes the door to The Shalom Project Medical Clinic on Friday at 633 W. Fourth St. in Winston-Salem. Centenary United Methodist Church has recently decided to sell the building where the clinic has been located for five years. The Shalom Project has three months to find a new home.

Foster had seen him the night before at Shalom’s free walk-in health clinic on Fourth Street and made sure the man — Craig — knew that he was welcome.

“We know a lot of people by first name,” Foster said. “I like it that way. It’s a good thing to hear people’s stories.”

Like many clients, Craig didn’t need to ask directions to the Shalom Project. They just know.

People are also reading…

But that’s about to change. And fast.

After 20 years on Green Street — and five for the group’s standalone medical clinic downtown on Fourth Street — the Shalom Project is hunting for a new home. And they have three months to find one.

Adapting to change

Unless you’ve been to the Shalom Project as a client, volunteer or a guest, it can be difficult to succinctly explain what it is they do.

The Shalom Project website describes it as outreach programs that challenge the cycles of poverty in the community. But since its founding in 2000, it’s become much more concrete.

“Our programs have morphed based on needs,” said Eileen Ayuso, the executive director.

As billed, the Shalom Project started as an outreach project targeting the working poor living along the Peters Creek Parkway between Ardmore and West Salem. “Between the slopes,” Ayuso calls it.

It began as a project of Green Street United Methodist with a clothes closet. A food pantry followed and then the walk-in medical clinic. Shalom turned into a standalone nonprofit in 2006 but remained in the basement of the church.

“We had an afterschool program for a while that the (YMCA) took over and a computer lab,” Ayuso said. “Remember when Internet cafes were a thing?”

Shalom changed along with the needs of the community.

“We kept asking the question, ‘What do people need?’” Foster said.

Available data — plus their own eyes and ears — steered the nonprofit toward the basics: food, clothing, shelter and medicine.

The clinic, which started at the church as well, was a huge step forward.

Dr. Stephen Bissette, a family practitioner, basically took it on as his own from the beginning and grew it into what Ayuso describes as the only free walk-in clinic in town — first-come, first-served, no appointments needed, every Wednesday night.

“He started this mess,” Ayuso said with a laugh.

The Shalom Project Administrative Offices at 639 S. Green St. in Winston-Salem.

That “mess” now sees 1,500 patients a year in a sprawling clinic on the bottom floor of a building owned by Centenary United Methodist Church.

Some 100 volunteers including physicians, nurses, medical students and pharmacists tend to the needs of the un- and underinsured homeless and working poor.

They can treat everything from cuts and scrapes to chronic conditions such as diabetes and hypertension. Patients can be examined and have prescriptions filled on site in under three hours.

And that’s in addition to the 1,200 families (4,000-some men, women and children) who rely on the food pantry at Green Street to fill gaps in refrigerators and cupboards, for the clothing store to supply gently-used apparel and, in some cases, for diapers and other toiletries.

“If you’re paying 80 percent of your income for rent, how can you afford everything else?” Ayuso said. “What do you skip?”

Meeting people’s needs, in other words.

Oh, and that doesn’t include the Peters Creek Community Initiative, an offshoot of the Shalom Project that will soon be building 62 new affordable housing units on land along Peters Creek Parkway where a run-down Budget Inn once stood.

“We got that with the help of the city and county,” Ayuso said. “We own the land, and now we’ve got $1.2 million in tax credits helping move it forward.”

Looking for a creative solution

Like every other nonprofit worth its salt, the Shalom Project has become adept at scrounging, writing grants and stretching its annual $450,000 budget.

“There’s probably a better way,” Foster said.

But that’s an annual dance, a way of life for organizations that largely depend on donations and outside sources for operating capital.

The more immediate need is finding a new home, one that will allow for constant change and expansion.

That’s been prompted by a accurate decision by Centenary to sell buildings it owns on Fourth Street, among the last under-utilized and undeveloped properties downtown, including one where the walk-in clinic set up shop five years ago.

Paige Daniel, a board member, volunteers to organize clothing in the The Shalom Project’s clothing closet on Friday. The clothing closet is at Green Street United Methodist Church,  639 S. Green St. in Winston-Salem.

Green Street had some modernization to do in its building, so something needed to be relocated to accommodate the work.

The clinic, which had outgrown its space, was the logical candidate. The move was supposed to be temporary, less than three months perhaps.

That was five years ago. Centenary offered room in one of its buildings, and a partnership of sorts was forged.

Nothing remains the same, and so it is with real-estate in a remade downtown.

But there are no hard feelings. Far from it, in fact.

“The church has been nothing but good to us,” Ayuso said. “They’ve been very gracious to us for five years.”

Rounding up staples and sorting donated clothing is one thing; finding a new location — especially for a health clinic — moving and setting up shop in a few months time is a different matter entirely.

The Shalom Project Medical Clinic on Friday at 633 W. Fourth St. in Winston-Salem.

Because the Shalom Project serves a population for which basic transportation can be an obstacle, a new place will need to be on (or very near) bus lines.

Ayuso and board members have started looking at potential new homes.

Ideally, Ayuso said, the Shalom Project could find space where it could consolidate all of its operations — a convenient, open one-stop shop.

That could be in a building owned by the city or county government or a private owner looking for a creative and tax-deductible use for an empty warehouse. The time crunch, however, may mean a temporary move for the medical clinic while the rest stays put at Green Street.

“It’s hard,” Ayuso said. “Expensive, too, especially for a nonprofit.”

Until a solution presents itself, folks at the Shalom Project will try to focus energy on meeting basic needs without interruption.

Still, it’s difficult not to wonder what might happen if time runs out.

“I don’t know,” Foster said. “I like that we’re pretty nimble and can get things done fast. But I don’t know.”

Jeffrey Dean Foster, program manager, stands for a portrait near the entrance of The Shalom Project Medical Clinic on Friday at 633 W. Fourth St. in Winston-Salem.

Sun, 09 Oct 2022 13:00:00 -0500 Scott Sexton en text/html https://journalnow.com/news/local/shalom-project-hunting-for-a-new-home-for-medical-clinic/article_932ce606-466e-11ed-bc6a-03df3b9ddf3a.html
Killexams : MoPH enhances efficiency of doctors in occupational health and safety in workplace

MoPH organises training workshop on occupational health basic services

Doha: The Ministry of Public Health recently organized a training program for practitioners and other specialty doctors on occupational health basic services, at Itqan Training Center.

The training program aims to enhance the competence of occupational health professionals and doctors working in primary health care, maintain the concept of highest quality of health and safety in the workplace, and understand the role of doctors in managing and preventing the implications of occupational diseases and incidents related to the environment.

The two-day training program was delivered by several experts and consultants in the field of occupational health and occupational medicine. As many as 36 practitioners and other specialty doctors from the Primary Health Care Corporation (PHCC), Qatar Red Crescent Worker Centers, other state institutions and corporate doctors were trained on basic occupational health services.  

During the training program, lectures were given and ways of dealing with clinical cases were provided  to enhance the knowledge and skills of participants about  work-related diseases, increase the ability to integrate the patient's professional history with the history of the disease and clinical examination, understand the importance and acquire the skills necessary to investigate the performance of occupational health and other examinations as necessary, and understand the role of the doctor in managing the occupational consequences due to the diseases and injuries such as job change and rehabilitation.

At the opening of the training program, Dr. Salah Al Yafei, Acting Director of Health Promotion and Non-Communicable Diseases at the Ministry of Public Health, commended the cooperation between the Ministry of Public Health and the concerned authorities in the country for organizing the program, which was delivered by 6 experts and consultants in occupational health from Qatar Energy Foundation, Hamad Medical Corporation and Qatar Airways.  

Dr. Salah Al-Yafei pointed out that workers in many countries are exposed to dealing with hazardous manufacturing materials, pointing out the urgent need to mitigate these risks and that there are several countries moving towards transforming their health system based on the principles and values of primary health care to provide services and achieve maximum benefit at a lower cost while ensuring high quality.

He stressed the importance of the role of the doctors participating in the training program who will contribute to improving the occupational health services provided, pointing out that the health sector in the State of Qatar looks forward to a strong and effective partnership between the government and private sectors in this field. 

For his part, Dr. Mohammed Ali Al-Hajjaj, Head of the Occupational Health Department at the Ministry of Public Health, pointed out that the training program completes the training of doctors working in primary health care.  A group of practitioners and other specialty doctors have been trained during the past years from different entities in the country as a part of the work plan to train medical staff in the field of occupational health services, stressing that the Ministry of Public Health is currently preparing a 10-day integrated training program in the same field in cooperation with the World Health Organization.

Dr. Mohammed Al-Hajjaj pointed out that the Ministry of Public Health seeks through the training program to achieve the maximum outputs of the Occupational Health Project within the Qatar Public Health Strategy 2017-2022, as  well as  the priority of (health and safe workers) within the National Health Strategy 2018-2022  , in addition  to transferring and enhancing the level of knowledge of occupational health and occupational medicine to primary health care doctors in order to support and Improve occupational health practices and service delivery, as this is reflected in the increase in medical practices to cover the shortage of  professionals in the field of occupational health, particularly primary health care doctors.
 

Sat, 15 Oct 2022 04:08:00 -0500 en text/html https://thepeninsulaqatar.com/article/15/10/2022/moph-enhances-efficiency-of-doctors-in-occupational-health-and-safety-in-workplace
Killexams : Shalom Project hunting for a new home for medical clinic, the only free, walk-in clinic in Winston-Salem

Jeffrey Foster, the program director at the Shalom Project, greeted the man who’d walked into the nonprofit’s offices Thursday morning like he was a regular customer at the corner store.

The man had popped into the Green Street United Methodist Church — currently a main location for the Shalom Project, a nimble do-everything nonprofit that meets those in need where they live — because he needed a few items. Clothing and toiletries mostly.

Jeffrey Dean Foster, program manager, closes the door to The Shalom Project Medical Clinic on Friday at 633 W. Fourth St. in Winston-Salem. Centenary United Methodist Church has recently decided to sell the building where the clinic has been located for five years. The Shalom Project has three months to find a new home.

Foster had seen him the night before at Shalom’s free walk-in health clinic on Fourth Street and made sure the man — Craig — knew that he was welcome.

“We know a lot of people by first name,” Foster said. “I like it that way. It’s a good thing to hear people’s stories.”

Like many clients, Craig didn’t need to ask directions to the Shalom Project. They just know.

People are also reading…

But that’s about to change. And fast.

After 20 years on Green Street — and five for the group’s standalone medical clinic downtown on Fourth Street — the Shalom Project is hunting for a new home. And they have three months to find one.

Adapting to change

Unless you’ve been to the Shalom Project as a client, volunteer or a guest, it can be difficult to succinctly explain what it is they do.

The Shalom Project website describes it as outreach programs that challenge the cycles of poverty in the community. But since its founding in 2000, it’s become much more concrete.

“Our programs have morphed based on needs,” said Eileen Ayuso, the executive director.

As billed, the Shalom Project started as an outreach project targeting the working poor living along the Peters Creek Parkway between Ardmore and West Salem. “Between the slopes,” Ayuso calls it.

It began as a project of Green Street United Methodist with a clothes closet. A food pantry followed and then the walk-in medical clinic. Shalom turned into a standalone nonprofit in 2006 but remained in the basement of the church.

“We had an afterschool program for a while that the (YMCA) took over and a computer lab,” Ayuso said. “Remember when Internet cafes were a thing?”

Shalom changed along with the needs of the community.

“We kept asking the question, ‘What do people need?’” Foster said.

Available data — plus their own eyes and ears — steered the nonprofit toward the basics: food, clothing, shelter and medicine.

The clinic, which started at the church as well, was a huge step forward.

Dr. Stephen Bissette, a family practitioner, basically took it on as his own from the beginning and grew it into what Ayuso describes as the only free walk-in clinic in town — first-come, first-served, no appointments needed, every Wednesday night.

“He started this mess,” Ayuso said with a laugh.

The Shalom Project Administrative Offices at 639 S. Green St. in Winston-Salem.

That “mess” now sees 1,500 patients a year in a sprawling clinic on the bottom floor of a building owned by Centenary United Methodist Church.

Some 100 volunteers including physicians, nurses, medical students and pharmacists tend to the needs of the un- and underinsured homeless and working poor.

They can treat everything from cuts and scrapes to chronic conditions such as diabetes and hypertension. Patients can be examined and have prescriptions filled on site in under three hours.

And that’s in addition to the 1,200 families (4,000-some men, women and children) who rely on the food pantry at Green Street to fill gaps in refrigerators and cupboards, for the clothing store to supply gently-used apparel and, in some cases, for diapers and other toiletries.

“If you’re paying 80 percent of your income for rent, how can you afford everything else?” Ayuso said. “What do you skip?”

Meeting people’s needs, in other words.

Oh, and that doesn’t include the Peters Creek Community Initiative, an offshoot of the Shalom Project that will soon be building 62 new affordable housing units on land along Peters Creek Parkway where a run-down Budget Inn once stood.

“We got that with the help of the city and county,” Ayuso said. “We own the land, and now we’ve got $1.2 million in tax credits helping move it forward.”

Looking for a creative solution

Like every other nonprofit worth its salt, the Shalom Project has become adept at scrounging, writing grants and stretching its annual $450,000 budget.

“There’s probably a better way,” Foster said.

But that’s an annual dance, a way of life for organizations that largely depend on donations and outside sources for operating capital.

The more immediate need is finding a new home, one that will allow for constant change and expansion.

That’s been prompted by a accurate decision by Centenary to sell buildings it owns on Fourth Street, among the last under-utilized and undeveloped properties downtown, including one where the walk-in clinic set up shop five years ago.

Paige Daniel, a board member, volunteers to organize clothing in the The Shalom Project’s clothing closet on Friday. The clothing closet is at Green Street United Methodist Church,  639 S. Green St. in Winston-Salem.

Green Street had some modernization to do in its building, so something needed to be relocated to accommodate the work.

The clinic, which had outgrown its space, was the logical candidate. The move was supposed to be temporary, less than three months perhaps.

That was five years ago. Centenary offered room in one of its buildings, and a partnership of sorts was forged.

Nothing remains the same, and so it is with real-estate in a remade downtown.

But there are no hard feelings. Far from it, in fact.

“The church has been nothing but good to us,” Ayuso said. “They’ve been very gracious to us for five years.”

Rounding up staples and sorting donated clothing is one thing; finding a new location — especially for a health clinic — moving and setting up shop in a few months time is a different matter entirely.

The Shalom Project Medical Clinic on Friday at 633 W. Fourth St. in Winston-Salem.

Because the Shalom Project serves a population for which basic transportation can be an obstacle, a new place will need to be on (or very near) bus lines.

Ayuso and board members have started looking at potential new homes.

Ideally, Ayuso said, the Shalom Project could find space where it could consolidate all of its operations — a convenient, open one-stop shop.

That could be in a building owned by the city or county government or a private owner looking for a creative and tax-deductible use for an empty warehouse. The time crunch, however, may mean a temporary move for the medical clinic while the rest stays put at Green Street.

“It’s hard,” Ayuso said. “Expensive, too, especially for a nonprofit.”

Until a solution presents itself, folks at the Shalom Project will try to focus energy on meeting basic needs without interruption.

Still, it’s difficult not to wonder what might happen if time runs out.

“I don’t know,” Foster said. “I like that we’re pretty nimble and can get things done fast. But I don’t know.”

Jeffrey Dean Foster, program manager, stands for a portrait near the entrance of The Shalom Project Medical Clinic on Friday at 633 W. Fourth St. in Winston-Salem.

Sun, 09 Oct 2022 13:00:00 -0500 Scott Sexton en text/html https://journalnow.com/news/local/shalom-project-hunting-for-a-new-home-for-medical-clinic-the-only-free-walk-in/article_932ce606-466e-11ed-bc6a-03df3b9ddf3a.html
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